Junshi Announces Its Anti-Covid Phase III Drug Reaches Primary Endpoint

Healthcare, Financials Author: Jizhen Huang May 24, 2022 03:45 PM (GMT+8)

Founded in August 2021, Juntuo Biotech is dedicated to the R&D processes in biomedicine and vaccines. The company's innovative R&D pipelines cover viral vaccines, bacterial vaccines, genetically engineered vaccines, conjugate vaccines, and multivalent vaccines.


Juntuo Biotech (Chinese: 君拓生物), a subsidiary of Junshi Biosciences (Chinese: 君实生物, HK:01877, SH:688180) announced that the pipeline VV116, the oral nucleoside anti-SARS-CoV-2 drug tablets, has reached the primary endpoints in the Phase III clinical study in a comparison with Nematevir /Ritonavir tablets (PAXLOVID) for the indication of early treatment of mild to moderate Covid-19. The pipeline is co-developed by Juntuo Biotech and Suzhou Vigonvita (Chinese: 苏州旺山旺水).

NCT05341609 trial is a multi-center, single-blind, randomized, controlled phase III clinical study to evaluate the efficacy and safety profile of VV116 versus Nematevir tablets/Ritonavir tablets (PAXLOVID).

The trial enrolled 822 patients. The primary endpoint was "time to sustained clinical recovery," and secondary endpoints included "percentage of subjects who developed COVID-19 progression by day 28". The results showed that VV116 met the primary endpoint prespecified in the protocol.

Junshi Biosciences disclosed in the announcement that it would communicate with regulatory authorities to submit new drug marketing applications in the near future.

According to public resources, Juntuo Biotech and Vigonvita made a cooperation deal to jointly undertake the pipeline clinical development and industrialization of VV116 in September 2021.

Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibodies in China. Its first-in-human anti-BTLA antibody for solid tumors was the first to be approved for clinical trials by the FDA and NMPA.

As of the press time, Junshi Biosciences shares are 16.11% lower to CNY 89.76 apiece on the A-share market. They slid 10% down to HKD 49.5 (USD 6.31) per share on Hong Kong Stock Exchange.